Device Recall RT5100 Refractor and RT3100 Refractor

  • Modèle / numéro de série
    RT-5100 and RT-3100, various serial numbers.
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    US distribution only.
  • Description du dispositif
    RT-5100 Refractor and RT-3100 Refractor; || Distributed by MARCO Opthalmic: || Manufactured by NIDEK CO., Ltd., Aichi, Japan. || Instrument provides means of positioning spherical and cylindrical lenses, prisms and other optical devices in front of a subject's eyes for purpose of determining refractive error and binocular functions.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Nidek Inc, 47651 Westinghouse Dr, Fremont CA 94539-7474
  • Société-mère du fabricant (2017)
  • Source
    USFDA